MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has ben completed.Please see the following related mfr report: mfr # 3010617000-2019-00016 for the lifeband.

Event Description

As reported, during shift check, the lifeband was unable to be installed to the autopulse platform (sn (b)(4)).No patient involvement.

Manufacturer Narrative

The reported event was confirmed through visual inspection of the autopulse platform (sn # (b)(4).The root cause is due to a sticky encoder drive shaft.Upon visual inspection, no physical damages were observed.Noticed that the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The clutch plate was deburred to remedy the fault.During initial functional testing, the platform passed the testing without any fault / error.The archive data review showed no errors.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8232776
• MDR Text Key: 132576120
• Report Number: 3010617000-2019-00015
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1