SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
|
Back to Search Results |
|
Catalog Number P310NUS |
Device Problem
Break (1069)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Event Description
|
It was reported that the device has a broken pressure gauge.Patient involvement is unknown.
|
|
Manufacturer Narrative
|
Other, other text: b3: date of event is unknown, no information received to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Manufacturer Narrative
|
No product was returned.The investigation was unable to determine the most probable cause as the device was not returned for evaluation.If the product is returned this complaint will be reopened for further investigation.Service history review identified the complaint was not related to a previous service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.
|
|
Search Alerts/Recalls
|
|
|