Manufacturing fault
All devices were disinfected and inspected following their use as per protocol. During this inspection, four devices were found to have an ineffective bulb pump (Figure 1) which resulted in inadequate cuff inflation (Table 1). Operators comments during the attempted births reflected this, as the device did not act in the expected manner for them.
D4: ‘Yes, there was no grip… It just came out deflated, so it didn’t feel right.’
A rapid retrospective review of all used and stored devices was then undertaken to ensure that no other unsuccessful attempts could be attributed to this fault.